Actively Recruiting
A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Led by Takeda · Updated on 2026-01-20
59
Participants Needed
52
Research Sites
163 weeks
Total Duration
On this page
Sponsors
T
Takeda
Lead Sponsor
T
Takeda Development Center Americas, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main aim of this study is to evaluate the pharmacokinetic (PK) comparability between TAK-881 and HYQVIA subcutaneous (SC) administration for maintenance therapy of CIDP. The participants who are already receiving intravenous immunoglobulin G (IGIV), conventional subcutaneous intravenous immunoglobulin G (cIGSC), or HYQVIA will be treated with the same dose equivalent as their prior IG treatment with HYQVIA for 20 weeks followed by TAK-881 for 24 weeks. Participants will need to visit the clinic every 3 or 4 weeks until they enter the extension phase. In the extension phase, home infusions are allowed, and visits will occur between every 12 weeks and 24 weeks.
CONDITIONS
Official Title
A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to comply with trial procedures
- Provided written informed consent
- Documented diagnosis of CIDP or possible CIDP per EFNS/PNS 2021 criteria by a neuromuscular specialist
- Previously responded to IgG treatment with partial or complete symptom resolution
- On stable IGIV, cIGSC, or HYQVIA treatment with monthly IgG dose 0.4 to 2.4 g/kg for at least 12 weeks before screening
- IGIV dosing interval between 2 and 6 weeks; cIGSC dosing weekly or biweekly; HYQVIA dosing up to 6 weeks
- INCAT disability score between 0 and 7 inclusive, meeting specified scoring conditions
- Negative pregnancy test if potential to become pregnant and agreement to use effective contraception during and 30 days after treatment
You will not qualify if you...
- Diagnosis of focal, multifocal, distal, or sensory CIDP or possible forms per EFNS/PNS 2021
- Neuropathy from other causes including hereditary neuropathies, infections, systemic diseases, MMN, or toxin-induced neuropathy
- Chronic or debilitating diseases affecting neurological assessment (e.g., multiple sclerosis, stroke, Parkinson's disease)
- Use of immunomodulatory/immunosuppressive agents other than IGIV, cIGSC, or fIGSC within 6 months
- Long-term corticosteroid use >20 mg/day prednisone-equivalent for >30 days within 3 months
- Plasma exchange within 3 months before screening
- IgM paraproteinemia or IgA deficiency with hypersensitivity to immunoglobulin treatment
- Conditions altering protein catabolism or IgG use (e.g., nephrotic syndrome)
- Chronic kidney disease with GFR <30 mL/min/1.73 m2
- Malignancy with less than 2 years remission or active cancer requiring treatment
- Severe heart conditions or uncontrolled hypertension
- Thrombophilic disorders or recent thromboembolic events
- Hypersensitivity to IGIV, IGSC, TAK-881, HYQVIA, hyaluronidase, or related excipients
- Positive for hepatitis B surface antigen, HIV, or active hepatitis C infection
- Clinically significant anemia or certain abnormal lab values
- Pregnant or lactating women
- Participation in another investigational trial within 12 weeks or 5 half-lives
- Trial site employees or immediate family members involved in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
HonorHealth Neurology
Scottsdale, Arizona, United States, 85251
Actively Recruiting
2
Stanford Neuroscience Health Center
Palo Alto, California, United States, 94304
Not Yet Recruiting
3
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Not Yet Recruiting
4
Neurology Associates
Maitland, Florida, United States, 32751
Actively Recruiting
5
Knight Neurology
Rockledge, Florida, United States, 32955
Actively Recruiting
6
The Washington University
St Louis, Missouri, United States, 63130
Not Yet Recruiting
7
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
8
University of North Carolina (UNC)
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
9
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
10
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
Actively Recruiting
11
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
12
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
13
Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic - Marquam Hill
Portland, Oregon, United States, 97239
Not Yet Recruiting
14
Neurology Rare Disease Center
Denton, Texas, United States, 76208
Actively Recruiting
15
The University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Not Yet Recruiting
16
BCN Research, LLC
Greenfield, Wisconsin, United States, 53228
Actively Recruiting
17
INECO
Rosario, Santa Fe Province, Argentina, 2000
Not Yet Recruiting
18
Instituto Argentino de Investigacion Neurologica (IADIN)
Buenos Aires, Argentina, C1015ABR
Not Yet Recruiting
19
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
Not Yet Recruiting
20
Copenhagen University Hospital
Copenhagen, Capital Region, Denmark, 2100d
Not Yet Recruiting
21
Aarhus Universitetshospital
Aarhus, Central Jutland, Denmark, 8200
Actively Recruiting
22
Universitätsklinikum Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany, 68167
Not Yet Recruiting
23
University of Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
Not Yet Recruiting
24
Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg
Marburg, Hesse, Germany, 35043
Not Yet Recruiting
25
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
Not Yet Recruiting
26
Charite - Universitatsmedizin Berlin
Berlin, Germany, 12203
Not Yet Recruiting
27
Attikon University General Hospital
Athens, Attica, Greece, 12462
Not Yet Recruiting
28
University General Hospital of Patras
Patras, Peloponnese, Greece, 26504
Not Yet Recruiting
29
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan, Lombardy, Italy, 20132
Not Yet Recruiting
30
IRCCS Istituto Clinico Humanitas
Rozzano, Milano, Lombardia, Italy, 20089
Not Yet Recruiting
31
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, Torino, Piemonte, Italy, 10043
Not Yet Recruiting
32
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, Italy, 25123
Not Yet Recruiting
33
Ospedale San Martino
Genova, Italy, 16132
Not Yet Recruiting
34
Az Ospedaliera Universitaria Policlinico G Martino
Messina, Italy, 98125
Not Yet Recruiting
35
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, Italy, 27100
Not Yet Recruiting
36
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126
Not Yet Recruiting
37
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Italy, 00133
Not Yet Recruiting
38
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital
Nagoya, Aichi-ken, Japan, 455-8530
Not Yet Recruiting
39
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan, 860-8556
Actively Recruiting
40
Tohoku Medical and Pharmaceutical University Hospital
Sendai, Miyagi, Japan, 981-8558
Not Yet Recruiting
41
Nara Medical University Hospital
Kashihara, Nara, Japan, 634-8522
Not Yet Recruiting
42
Higashimatsuyama Municipal Hospital
Higashi-Matsuyama, Saitama, Japan, 355-0005
Actively Recruiting
43
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan, 520-2192
Not Yet Recruiting
44
Tokushima University Hospital
Tokushima, Tokuchima, Japan, 770-8503
Not Yet Recruiting
45
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431
Actively Recruiting
46
Oddzial Kliniczny Neurologii
Krakow, Lesser Poland Voivodeship, Poland, 30-688
Not Yet Recruiting
47
Clinirem Sp zo.o.
Lublin, Lublin Voivodeship, Poland, 20-064
Actively Recruiting
48
Warszawski Uniwersytet Medyczny
Warsaw, Masovian Voivodeship, Poland, 02-097
Not Yet Recruiting
49
Copernicus Podmiot Leczniczy
Gdansk, Pomeranian Voivodeship, Poland, 80-462
Not Yet Recruiting
50
Hospital de La Santa Creu I San Pau
Barcelona, Spain, 08041
Not Yet Recruiting
51
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Not Yet Recruiting
52
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götaland County, Sweden, 41345
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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